RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of December 16, 2024 No. 759

About approval of Storage precautions of medicines and medical products

For the purpose of implementation of article 30 of the Law of the Kyrgyz Republic "About drug circulation", article 25 of the Law of the Kyrgyz Republic "About the address of medical products", according to articles 13, of the 17th constitutional Law of the Kyrgyz Republic "About the Cabinet of Ministers of the Kyrgyz Republic" the Cabinet of Ministers of the Kyrgyz Republic decides:

1. Approve Storage precautions of medicines and medical products according to appendix.

2. Determine that the realization of this resolution is enabled:

1) within approved budgets and the number of staff of the involved state organizations of health care and pharmaceutical institutions for the corresponding years;

2) at the expense of own funds of the raised the organizations of health care, the pharmaceutical organizations with private pattern of ownership and state companies.

3. Declare invalid the order of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safe Storage of Medicines in the Pharmaceutical Organizations and the Organizations of Health Care and the Sanitary Mode of the Pharmaceutical Organizations" of September 25, 2012 No. 646.

4. This resolution becomes effective after fifteen days from the date of official publication.

Appendix

to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic of December 16, 2024 No. 759

Storage precautions of medicines and medical products

Chapter 1. General provisions

1. These rules of storage of medicines and medical products (further - Rules) establish safety requirements to stores organization of various groups of medicines and medical products in the pharmaceutical organizations and the organizations of health care irrespective of pattern of ownership and departmental accessory.

2. Requirements of Rules extend to all pharmaceutical organizations (drugstores of ready dosage forms, pharmaceutical Items and booths, drugstores with the right of production of medicines, warehouses) which are in the territory of the Kyrgyz Republic, irrespective of pattern of ownership and departmental subordination.

3. In Rules the following terms and determinations are used:

1) storage of medicines and medical products - process of placement (warehousing) of products with providing storage conditions from the moment of receipt and until obtaining by the consumer;

2) storage in the dark place - storage of medicines, medical products in the place protected from sunlight;

3) storage in the dry place - storage of medicines, medical products in rooms with relative humidity of air no more than 60%;

4) storage in the cool place - storage of medicines, medical products at temperature from +8 to +15 hail. Celsius;

5) storage at the room temperature - storage of medicines, medical products at temperature from +15 hail. to the +25th hail. Celsius (including if temperature is not specified);

6) refrigerating element (further - hladoelement) - plastic or squared metal reservoir with airtight stopper for filling with water which is refrigerated before use and serves for maintenance of temperature in container ranging from the +2nd hail. Celsius to the +8th hail. Celsius;

7) thermal container - box (or bag) for transfer of medicines, the medical products requiring protection against impact of the increased temperature with the heat-insulating properties and skintight cover, where optimum temperature condition (from the +2nd hail. Celsius to the +8th hail. Celsius) it is provided by means of the refrigerated refrigerating elements placed in his cavity;

8) rooms of storage - specially allocated and equipped production rooms intended for storage of medicines, medical products;

9) sanitary clothes - the scrub, hat and bandage intended for protection of medicines, materials and finished goods against the additional microbiological and other pollution allocated by personnel;

10) medicine expiration date - time established for use of medicines during which their safety, efficiency and proper quality in case of observance of storage conditions is guaranteed.

4. Placement on the areas of the pharmaceutical organizations which are functionally not connected with the pharmaceutical organization is not allowed.

Chapter 2. General requirements of safety to storage of medicines and medical products

5. The device, structure, the sizes of the areas and the equipment of rooms of storage of medicines and medical products shall meet the requirements established by regulatory legal acts in the sphere of licensed and allowing activities.

The device, operation and the equipment of rooms of storage shall ensure safety of medicines and medical products.

6. Rooms of storage shall meet the established standards of protection and fire safety.

7. Certain temperature and humidity of air which check shall be performed at least 1 time a day shall be maintained in rooms of storage. For observation of these parameters storage facilities need to be provided with thermometers and hygrometers which are fixed on internal walls of storage, far from heating devices, at m 1,5-1,7 height from floor and at distance at least 3 m from doors. Indications of these devices without fail are subject to registration.

8. For maintenance of purity of air of the room of storage it is necessary to equip with supply and exhaust ventilation with mechanical motivation. In case of impossibility of the equipment of rooms of storage the supply and exhaust ventilation recommends to equip window leaves, transoms, the second trellised doors, etc.

9. Pharmaceutical warehouses and drugstores are equipped with devices of central heating. Heating of rooms by gas devices with open flame or electric heaters with open electrospiral is not allowed.

10. In warehouses and in the drugstores located in climatic zone with big variations from admissible regulations of temperature and relative humidity of air, rooms of storage shall be equipped with conditioners and if necessary supply and exhaust ventilation.

11. Rooms of storage shall be provided with necessary quantity of racks, cases, pallets, podtovarnik, etc.

Installation of racks is performed so that they were at m 0,6-0,7 distance from external walls, m 0,5 from ceiling of at least 0,25 of m from floor suffices. Racks in relation to windows shall be located so that passes were lit, and the distance between racks made at least 0,75 of m and provided open entry to goods.

12. Premises of the pharmaceutical organizations shall be kept clean, floors of rooms periodically (but at least once a day) shall clean up by damp method using the permitted detergents.

13. Medicines in rooms of storage need to be placed taking into account the most complete space occupancy, creation of the best working conditions for employees of the pharmaceutical organizations, possibility of application of means of mechanization and providing pharmaceutical procedure.

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